Jazz Pharmaceuticals' Late-Stage Multiple Sclerosis Study Misses Primary Endpoint


Jazz Pharmaceuticals JAZZ announced top-line results from the Phase 3 clinical trial investigating nabiximols oromucosal spray (JZP378) on clinical measures of spasticity in individuals with multiple sclerosis (MS).

The RELEASE MSS1 study evaluated the safety and efficacy of nabiximols oromucosal spray in 68 patients with multiple sclerosis (MS) spasticity, was the first and smallest, of the three clinical trials in the current program.

The clinical trial failed to meet the primary endpoint of change in Lower Limb Muscle Tone-6 (LLMT-6) between baseline and Day 21, as measured by the Modified Ashworth Scale (MAS).

Rob Iannone, M.D., M.S.C.E., executive vice president, said, “We remain committed to the nabiximols program and are actively assessing the RELEASE MSS1 trial results. We look forward to additional data from two other ongoing trials that have the potential to support a U.S. FDA New Drug Application submission.”

The company is planning to share data readout from the RELEASE MSS1 study in a future medical meeting.

Jazz shares are trading down 1 percent at $155.61

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